Transcript No Slide Title

How to Prepare for
Ethical Review by the
Fraser Health Research
Ethics Board
Presented by: Susan Chunick
Director, Research Administration and Development
October 12, 2007
Objectives:
By the end of the workshop, you will be able to:
1.
Submit an application for initial ethical review that meets the
requirements of the FH ethics review process;
2.
Prepare an application that takes into account the ethical principles
considered in the ethical review by the FH Research Ethics Board
[REB];
3.
Understand the decision-making process used by the FHREB in
conducting an ethical review;
4.
Understand the differences between a Full Board versus an
Expedited Review of initial applications, amendments, renewals and
serious adverse events;
5.
In general, describe the standard wording requirements for consent
forms;
6.
Design a consent form using the FH standard template, and;
7.
Describe the fundamental differences in consent forms used for
genetic studies and incompetent subjects.
But first, some background:
WHO IS THE FH REB?
Meets TCPS & Health Canada quorum requirements
Research Ethics Co-ordinator:
Rosa Haywood
Ex-officio:
Susan Chunick
WHO IS THE FH REB?
Meets TCPS & Health Canada quorum requirements
Co-Chairs:
•
•
Dr. Allan Belzberg [SMH nuclear medicine]
Dr. Marc Foulkes [RCH anaesthesia]
Clinical Experts:
•
•
•
•
Bob Gillies, Ph.D
[SMH Pharmacy]
Michael Vince, Ph.D [retired FH biochemist]
Dr. Arthur Friesen
[RCH Cardiologist]
Arun Chockinglam, Ph.D [SFU health services
researcher]
WHO IS THE FH REB?
Ethicist:
Lindsay Meredith, Ph.D [SFU]
Statistician:
Michael Wasdell, M.A. FH Research Administration and
Development
Legal Representation: non-FH
Ms. Camille Ciarniello [LLB]
Ms. Mara Stickland
[LLB]
Lay member:
Mrs. Nancy Magnee
WHAT IS THE SCOPE OF THE
FHREB?
Research versus Evaluation
WHAT IS THE SCOPE OF THE
FHREB?
What is Research?
Research involving human subjects is defined as any systematic
investigation (including pilot studies, exploratory studies, and
academic course work assignments) designed to contribute to
generalizable knowledge.
Generalizable knowledge consists of facts, theories, principles or
relationships, or the accumulation of information on which they
are based, that can be corroborated by accepted scientific
methods of observation and inference.
Generalizable means knowledge that can be applied beyond the
specific situation in which the work was conducted. [Government of Canada.
Refinements to the Proportionate Approach to Research Ethics Review in the TCPS, December 2005]
WHAT IS THE SCOPE OF THE
FHREB?
•
Clinical Research
– Includes research on *animal models of
human disease, clinical trials and other
therapeutic interventions.
– E.g. Testing the effectiveness of a new
medication, a new rehabilitation treatment,
a new pharmacy intervention, a new
assessment tool
WHAT IS THE SCOPE OF THE
FHREB?
•
Health Services/Systems Research
– Multidisciplinary field
– Aims to improve the efficiency and
effectiveness of health professionals and
the health care system.
– Interventions at the level of practice and
policy.
– i.e. Evaluating a new intervention for
improving patient flow.
WHAT IS THE SCOPE OF THE
FHREB?
•
Population Health Research
– Studies the impact of social and environmental
factors on the health of
populations/subpopulations.
– May examine social, cultural, environmental,
occupational, and economic factors that determine
health status.
– Research data is used to identify areas where the
health of a population can be improved.
– i.e. Statistics Canada Community Health Survey.
WHAT IS THE SCOPE OF THE
FHREB?
What is Evaluation?
"the systematic application of social
research procedures for assessing the
conceptualization, design,
implementation, and utility of ...
programs."
Source: J. Krajnak: Rossi and Freeman (1993)
WHAT IS THE SCOPE OF THE
FHREB?
Clarification of Ethical Review Requirements for
Studies Involving Quality
Assurance/Improvement, Program Evaluation,
Operational Review and Product Evaluation
•
Approved by FH Executive Committee: 2005/09/27
RESEARCH ETHICS BOARD
STATUS REPORT 01 October 2007
Total Studies 388
(From 2005 September 01 to Date)
ACTIVE STUDIES =204
Type of Ethics Review for
ACTIVE Studies
PENDING APPROVAL = 18
Funding for ACTIVE Studies
80
79
60
110
F ull B o a rd
94
E xpe dit e d
72
40
38
20
0
2
8
Sponsor
Grant
Grant-A id
Unfunded
FH Internal
5
Other
Active Studies by Department Area
Addiction Services
1
Finance
1
Neurology
3
Pharmacy
17
Administration
1
Food & Nutrition
1
Nursing
5
Prevention/Promotion
1
Anaesthesia
1
Health Services
2
Nutrition
1
Professional Practice
4
Cardiology
27
Home Health
1
Obstetrics
6
Psychiatry
18
Community Site
1
Infection Control
1
Occupational Therapy
2
Public Health Prevention
1
Critical Care (ICU)
13
Information Management
1
Oncology
5
Residency Facility
1
Decision Support Service
1
Internal Medicine
2
Orthopaedics
15
Respiratory
1
Diversity Services
1
Laboratory-Cytology
1
Palliative Care
2
Social Work
3
Elder Research
3
Medicine
6
Pathology
1
Surgery
2
Emergency
7
Mental Health
6
Paediatrics
2
Systems
Analysis/Performance
1
Ethics
1
Multiple Sclerosis
8
People Service
1
Workplace Health
7
Family Medicine
3
Nephrology
5
Perinatal
2
Non FH Research
8
WHAT IS THE SCOPE OF THE
FHREB?
Degree of FHREB Oversight in Proportion to Probability &
Magnitude of the Risk of Harms
Continuum of risk of harms can encompass the following
determinants, e.g.:
• Invasiveness of intervention
• Intrusiveness of data collection
• Toxicity of intervention
• Vulnerability of subjects
• Sensitivity of information
• Availability of risk mitigation strategies
• Potential for conflict of interest – i.e. industry sponsored
WHAT IS THE SCOPE OF THE
FHREB?
Degree of FHREB Oversight in Proportion to Probability
& Magnitude of the Risk of Harms
Harms can include potential for:
• Physical injury/adverse event
• Emotional or psychological injury
• Social harm [e.g. loss of insurance, employability]
• Financial harm
• Breach of confidentiality
• Loss of trust
WHAT IS THE SCOPE OF THE
FHREB?
Degree of FHREB Oversight in Proportion to
Probability & Magnitude of the Risk of Harms
Expedited/Delegated Review for ‘minimal risk’
studies.
 Review delegated to FHREB co-Chair
 FHREB co-Chair may refer to FHREB
 “Expedited” versus “Speedy”

WHAT IS THE SCOPE OF THE
FHREB?
Expedited Review for Minimal Risk Studies
involving ‘Vulnerable’ Subjects
• Secondary Sources of Data:
Retrospective Chart review – no
consent required
• Prospective Observational research:
Primary sources of data – consent
required
WHAT IS THE SCOPE OF THE
FHREB?
Ethics Review and Approval BEFORE any
contact with prospective subjects
and/or data collection begins.
WHAT IS THE SCOPE OF THE
FHREB?
Ethics Review and Approval UNTIL ALL
data collection is completed.
Obligations of the FHREB:
•
The Ethical Review Process is
transparent and meets obligations
according to international and national
guidelines and legislation, provincial
legislation and FH policies.
•
Researchers meet their obligations
according to international and national
guidelines and legislation, provincial
legislation and FH policies.
Obligations of the FHREB:
What are the main FHREB obligations?
 To
protect human subjects
 To preserve rights of human subjects
TCPS and Health Canada
ALL CANADIAN RESEARCH:
TCPS = The Tri-council Policy
Statement on Ethical Conduct for
Research Involving Human
Subjects [1998 + updates]
http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm
ALL CANADIAN CLINICAL
DRUG/DEVICE TRIALS: Health
Canada = Food and Drug Act
Regulations
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/index_e.html
Why Should We Worry About
Protecting Human Subjects?
The Recent Past:
[2002] Ryan Lucio – Children’s Hospital-Ottawa
[2001] Ellen Roche – Johns Hopkins
[1999] Jessie Gelsinger – U Penn
[1998] Hoiyan Wan – U Roch
[1997-2001] Nancy Olivieri – U of Toronto
The Distant Past:
•
Nuremberg NAZI Doctors Trial
•
PHS Syphilis Study – Tuskegee,
Tennessee
Governing Legislation,
Guidelines
WORLD MEDICAL ASSOCIATION /INTERNATIONAL
•
1964
Declaration of Helsinki
•
1997
ICH Good Clinical Practice Guidelines
UNITED STATES for U.S. Government Funded Studies
•
1979
Belmont Report: 45 CFR 46; 21 CFR 50,56
•
1983
45 CFR 46: Subpart D (children)
•
1991
Common Rule: 17 U.S. Agencies
•
2001
Association of American Universities Conflict of
Interest Guidelines
…Con’t
Governing Legislation, Guidelines
CANADA
1998 Health Canada: Food & Drug Act Medical Device Regulations
1998 Tri-Council Policy Statement on Ethical Conduct for Research Involving
Humans
2001 Health Canada: Regulations Amending the Food & Drug Act – Clinical Trials
2002
FOIPPA – Freedom of Information and Protection of Privacy (B.C.) Section
35 Amendment re “Disclosure for research or statistical purposes”
2002
Health Canada: CIHR Requirements for Ethical Review of Pluripotent Stem
Cell Research
2004 Health Canada: Natural Health Products Regulations Part 4 – Clinical Trials
2004 Personal Information Protection Act of BC (PIPA)
2004 Canada: Personal Information Protection and Electronic Documents Act
(PIPEDA)
FH POLICIES AND
GUIDANCES:
2005 April 12; Revised 2007 Jan:
•
“Ethical Conduct of Research & Other Subjects Involving
Human Subjects”
2005 June 21: *Revised 2007 Jan:
•
•
•
“FH Research”*
“The Collection, Use and Disclosure of Personal Information
for Research-related Purposes”
The Provision of Research-related Services to NonResearchers
2007 January: Research Integrity Policy
FHREB GUIDANCE NOTES and POLICIES
Some Definitions
APPLICATION FORMS
http://www.fraserhealth.ca/Initiatives/Research/Forms+and+Templates.htm
1.
2.
Initial Application: one application regardless of study type
Amendment Application for Previously Approved Research:
Changes to a protocol:
 genetic testing, new genetic tests or tissue banking where genetic
testing may or will be performed;
 open label extension phase following a randomized trial;
 emergency amendments
 change in drug dosing/duration of exposure/intervention
 decrease in monitoring [esp. clinical trials],
 change in recruitment technique
 change in experimental procedure or study population.
Some Definitions
APPLICATION FORMS
http://www.fraserhealth.ca/Initiatives/Research/Forms+and+Templates.htm
3.
4.
Request for Annual Renewal Form
Close-out Forms [Non-clinical & Clinical]
*Clinical Trial specific
5.
Serious Adverse Events Forms [Local & International]
6.
Protocol Deviation
Some Definitions
RESEARCHER RESPONSE FORM
http://www.fraserhealth.ca/Initiatives/Research/Forms+and+Templates.htm
1.
Revision of Research Studies for Removal of Modifications
Required or Deferred Status
a.
IF Modifications Required:


b.
Does not require Full Board review
Reviewed & approved under Expedited Review
IF Study Deferred:

Requires resubmission to Full Board for review*
FEES
 $2500
fee required for studies that are
industry-sponsored ONLY
 Grant
funded and unfunded studies are
exempt
The Ethical Review Process
Full Board Review: Greater Risk
Expedited Review: Minimal Risk
Schedule: All board members meet 2nd
Tuesday of every
Schedule: Reviews conducted weekly by one
of the FHREB co-chairs
Meeting Agenda:
•New applications,
•Amendments & renewals that require FB
review [regulated clinical trials only or co-Chair
refers from Expedited Review]
•Researcher’s responses to Deferral memo
•Policy, procedures, education
Review Agenda:
•New applications,
•Amendments & renewals,
•Serious adverse events,
•Protocol deviations
•Researcher’s responses to modifications
memo
Application Process:
•Mail in 12 copies of all documents 2 weeks
before meeting date to Rosa Haywood
•Pre-review** conducted
•Documents sent to members 1 week before
meeting
Application Process:
•Email the documents [i.e. one copy only] in at
any time to Rosa Haywood; Signature page may
month*http://www.fraserhealth.ca/Initiatives/Research/Ethics/Ethics+Customer+
Service.htm#Meeting
be faxed
•Pre-review**
conducted prior to review
•Documents received 1 business day before
the review date will be reviewed
The Ethical Review Process
Full Board Review: Greater Risk
Expedited Review: Minimal Risk
Meeting Process:
•Discuss & approve protocol*, Investigator’s
Brochure**, consent forms, questionnaires,
recruitment notices, other documentation
•Input from clinical experts, lawyer, ethicist,
lay person.
Review Process:
•Co-chair reviews protocol*, consent forms,
questionnaires, recruitment notices, other
documentation
•Summary document sent to FHREB with
decision for ‘approval’.
Decisions:
•Modifications Required***
•Deferral****
•Deferral with External Peer Review
Decisions:
•Approval
•Modifications Required
•Referral to Full Board
92%
8%
Decision Criteria:
•Study Deferred if research design/statistical
design/sample size incapable of answering
research question, if information re risks/risk
mitigation is insufficient.
•Modifications Required if clarifications
required are not substantive in nature, i.e.
application/consent form inconsistencies &/or
inaccuracies.
•External Peer Review if additional scientific
52%
48%
Decision Criteria:
Modifications Required if research
design/statistical design/sample size incapable
of answering research question.
Modifications Required if clarifications required
that are not substantive in nature, i.e.
application/consent form inconsistencies &/or
inaccuracies.
Referral to Full Board if additional expertise
required.
The Ethical Review Process
Full Board Review: Greater Risk
Expedited Review: Minimal Risk
Timelines [business days]:
Email of Decisions: 5 days
92%
Timelines [business days]:
Email of Decisions:
3 days
Meeting to Approval [median]
39.5 days
Review to Approval [median]
4.5 days
Full Board Review:
DR. FRANK ERVIN:
IMPROVE IT - Improved Reduction of Outcomes: Vytorin Efficacy International Trial: A
multicentre, double-blind, randomized study to establish the clinical benefits and safety of
Vytorin (Ezetimibe/Simvastin tablet) vs. Simvastin monotherapy in high-risk
ACUITY - A Randomized Comparison of Angiomax (bivalirudin) vs. Heparin (unfractionated
heparin or enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary
Syndrome Without ST-Segment Elevation
DR. GERALD SIMKUS [RCH]
PLATO - A Randomized, Double-Blind, Parallel Group, Phase 3, Efficacy and Safety Study of
AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with NonST or ST Elevation Acute Coronary syndrome (ACS)
DR. SEAN KEENAN [RCH]:
DECRA - Multi-Centre Prospective Randomised Trial of Early Decompressive Craniectomy in
Patients with Severe Brain Injury
DR. GALINA VOROBEYCHIK [BH]:
A 12-month, Double-blind, Randomized, Multicenter, Active-Controlled, Parellel-Group Study
Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY20) Administered
Orally Once Daily Versus Interferon b-1a (Avonex®) Administered i.m. Once Weekly
Expedited Review – Minimal
Risk
DR. DANTE MANYARI –
Canadian Congestive Heart Failure Network National Registry
Database
DR. SONIA SINGH –
Mechanism of Falls in the Elderly
HOLLY KENNEDY-SYMONDS –
Evaluation of Novel Balistocardiograph Analysis Methods
JOAN ARNOLD –
Consumption of a Liquid Meal Replacement in Hospitalized
Patients: An Anonymous Observational Study
SUBMISSION PROCESS:
Refer to Guidance Notes for specific
guidance related to the application form
at :
http://www.fraserhealth.ca/Initiatives/Res
earch/Forms+and+Templates.htm
Initial Application Requirements:
Problem Areas

APPLICATION FORM FOR INITIAL ETHICAL
REVIEW
Application form information must be consistent
with protocol, subject consent form(s) & other
documentation
Pages 1& 2:
•
Primarily administrative
•
Signatures must be obtained BEFORE review.
•
Document version # and dates must be included.
•
*New requirement: Clinical Trial Registration
•
Contact information
Application Requirements:
Problem Areas
Box 20: Recruitment methods
– see Guidance Note 17 and 18
Box 22: Description of Procedures
- related to Box 7 use of the ‘DAR’ form – Department
Agreement for Providing Research Related Services
Box 25: Risks
- See Guidance Note 22
- use template provided
-quantify all measurable risks
-can include psychological and social risks of harm
Application Requirements:
Problem Areas
Box 31: Confidentiality: Guidance Note 28
28a. Will the data be completely anonymized (i.e. the data
becomes anonymous because it is completely stripped of all
identifiers such that there is no possibility of re-linking data to
the subject’s identity)?
Yes
No
28b. If NO, will the data be “de-identified” by using a unique code
ONLY before leaving the FH site? Yes
No
28c. If YES, describe how the data will be “de-identified”.
28d. If NO, describe what identifier(s) will be used. E.g. DOB*
28e. Clarify where the data will reside. Will it be kept at FH or
sent elsewhere. Specify location if sent offsite.
Application Requirements:
Problem Areas
Box 35: Competency, Consent and Assent –
See Guidance Note 35 and Policy #17
No legal age of ‘consent’ for research in B.C.
Competency: TCPS states that competence (capacity to consent)
consists in "the ability of prospective subjects to give informed consent
in accord with their own fundamental values. It involves the ability to
understand and to appreciate the potential consequences of a
decision..."
Appreciation: assumes adequately developed adult capacities for
forming and revising personal values.
Understanding: ability to discern in significant measure the nature of
the research and the consequences of choosing/forgoing participation
in it.
Application Requirements:
Problem Areas
Children under 7 :
parental/legally authorized rep consent
Children between 7 and 13:
• assent form &
• parental/legally authorized rep consent form
Children 14 and older:
• parental/legally authorized rep consent &
• statement of signed assent in the consent
ETHICAL PRINCIPLES
& REB Obligations
•
Pre-study implementation: Study Value
•
Subject recruitment
•
Consenting Process
•
Study Implementation
•
Data Analysis
ETHICAL PRINCIPLES
& REB Obligations
Study Value:
Ethical Principle: Beneficence
‘Maximize possible benefits and minimize
possible harms’
ETHICAL PRINCIPLES
& REB Decisions
Does the science have value??
For experimental research: Is there
clinical equipoise?
•
•
•
•
•
•
Literature review
Testable hypothesis/endpoints/outcomes
specified
Placebo justification
Adequacy of peer review (FB only)
Sufficient sample size (power)
Do benefits outweigh possible risks?
ETHICAL PRINCIPLES
& REB Decisions
Recruitment
Ethical Principle:
Distributive Justice
“fairness in distribution” of the risk
of harms and benefits among the
population
ETHICAL PRINCIPLES &
REB Decisions
•
Inclusion Criteria
– Do inclusion criteria unfairly put one group
at risk of harm versus other potential
subjects?
•
Exclusion Criteria
– Do exclusion criteria provide valid reasons
for excluding subjects based on for e.g.
culture, religion, language, race, sex, age,
mental or physical capacity?
ETHICAL PRINCIPLES
& REB Decisions
Recruitment
Ethical Principle: Respect
“treat individuals as autonomous
agents”
ETHICAL PRINCIPLES &
REB Decisions
•
Subject Identification
– Protect privacy [FOIPPA]
– Section 35 prohibits using personal
information for contact if collected for a
non-research purpose, i.e. medical records
•
Initial Contact
– If Principal Investigator is primary caregiver, ensure non-coercive contact
– No inducements: subjects must not be
encouraged to trade incentives for risks
ETHICAL PRINCIPLES &
REB Decisions
Obtaining Consent:
“The consent form is not meant to
reassure the subject, quite the contrary,
it is meant to raise every possible
concern that might be relevant to the
subject’s participation.”
•
Time 2002 April 22
The Consent Form:
Three basic elements:
1.
1.
Complete and Accurate Information
Readable
-well organized
-lay terms
-grade 7 level
3. Voluntary
avoid coercion and undue influence
FH REB Consent Form Templates at
http://www.fraserhealth.ca/Initiatives/Research/Ethics/Ethics+Initial+Application.htm#Consent
•
•
•
•
•
Main Consent Form
Optional Research, e.g. genetic testing
Assent Form
Consent to Screen
Consent to Contact
ETHICAL PRINCIPLES &
REB Decisions
Consenting to Participate
Ethical Principle: Respect for free
and informed consent throughout
the study
“treat individuals as autonomous
agents”
ETHICAL PRINCIPLES &
REB Decisions
•
Ensure Non-coercive Consent Process
– Time to consent > 24 hours
– CF: Voluntary decision
– CF: Informed decision:
• Opportunity to ask questions
• Full disclosure* of all information in lay
terms including alternatives if therapy
• Opportunity to withdraw at any time
ETHICAL PRINCIPLES &
REB Decisions
During the Study: Ongoing
Consent
Ethical Principle:
Non-maleficence
“duty to avoid, prevent, or minimize
harms to others”
ETHICAL PRINCIPLES &
REB Decisions
Risk of Harms:
Full Board Review of Clinical Trials:
The risk of harms to the subject of participating in the study
has been evaluated by the FHREB. The FHREB agrees that
the foreseeable harms to this subject population do not
outweigh the anticipated benefits to society and that the
foreseeable harms are documented in the written consent
form compared to the review of the Investigator’s Brochure
for this study. In addition, the FHREB agrees that the risk
management strategies described in the consent form to
prevent, mitigate and/or manage the occurrence of harms are
reasonable and reflect current medical practice.
ETHICAL PRINCIPLES &
REB Decisions
•
Minimize Harms
–
–
–
–
Provide stopping rules; rescue medication
CF: Emergency contact information
CF: New information re harms
CF: Compensation for research-related
harms
– CF: Legal rights
– CF: How to withdraw
– CF: Subject rights
ETHICAL PRINCIPLES &
REB Decisions
Data Analysis
Ethical Principle: Respect
“ do not harm”
ETHICAL PRINCIPLES &
REB Decisions
•
•
•
•
Is collection of personal data limited to
essential information for study purposes?
Is consent obtained for collection/use of data?
Are subjects informed about possible uses of
research data?
How is confidentiality of subject data
maintained?
- Removal of personal identifiers, i.e. initials, name,
PHN, etc.
- Secure storage of data [preventing breach of
confidentiality]
Consent Form Review
•
•
•
•
•
•
•
•
•
•
MODIFICATIONS REQUIRED MEMORANDUM
TO:
Dr. Wendy Gordon
Pharmacy Department, Royal Columbian Hospital
FROM:
Dr. Marc Foulkes
Co-Chair, Fraser Health Research Ethics Board
DATE:
2007 September 11
RE:
FHREB 2007-070
National, Prospective, Observational Cohort Study of
Venous Thromboembolism Management with the Low
Molecular Weight Heparin, Enoxaparin, in the Outpatient
Setting in Canada
Research Protocol – Dated 2007 March 22. Application Form Dated
2007 August 27. Consent Form Version #1 2007 August 27.
Consent Form Review
If health records are to be accessed; this should be noted in the consent form.
Page 1
Under Investigator: Add “Principal” before “Investigator” and identify the hospital site, i.e.
Royal Columbian Hospital.
Under Background: Clarify that the subject is also being invited to participate because they are
being prescribed Enoxaparin for the initial treatment of VTE and that treatment will be ‘at
home’.
1st paragraph: Use lay terms for “prospective, observational’. Briefly explain why this study is
important.
Include the following wording required for industry-sponsored studies under a separate heading
as follows: Who is Conducting the Study? This consent document is to enable participation
in a clinical research protocol. The protocol has been sponsored by sanofi-aventis Canada
Inc. The physicians and other health care personnel, who are conducting this research, will
receive funds or other payment in return for the work required in doing clinical research.
These funds, from the sponsoring organization, are associated with obligations, defined in a
signed contractual agreement. Researchers must endeavor to serve both the interests of
the patient/subject and abide by contractual obligations with the sponsor.
Move the 2nd, 3rd and 4th paragraphs beginning “This study is non-interventional ….” to the
section “What will Happen During the Study?” .
2nd paragraph: Use lay term for “non-interventional”.
3rd paragraph. Use lay terms for “concomitant”, “anti-platelet agents or NSAIDS”.
•
Consent Form Review
Page 2:
•
•
•
Include a section on Who Can Participate in this Study? and delete “If you
correspond to the population….in this study”, as the inclusion criteria should be
specific.
Enoxaparin should be named as the LMWH used.
Under What Will Happen in the Study: State explicitly how the data collection
will occur:
–
–
–
•
Explain how the follow up data will be collected, i.e. by telephone?, by whom?
–
•
•
Is this data collection over and above the collection of routine information? The
application form box 24 b states that the time for subject involvement over and above
routine care will be 1 hour. Clarify this in the consent.
Does the subject have to return for a separate visit for the data collection? Clarify.
Does the subject have to respond to questions that are different from what would be
routinely asked? Clarify.
The protocol, p. 17 states that a contact person will be identified in the baseline CRF.
The consent form must explain that a contact name for future follow up will be
required.
Put the paragraph beginning “No direct benefit….” under a separate heading
titled “What are the Benefits of Participating?”
Include a separate paragraph that explains possible risks if any titled “What Are
The Possible Harms And Side Effects Of Participating?”
Consent Form Review
Page 2 continued:
• Under Is My Participation Voluntary? 1st
paragraph:
– Clarify that the subject can contact the
investigator by any means convenient to them to
explain that they are withdrawing. 2nd paragraph:
– Explain under what circumstances the subject may
be withdrawn from the study.
– Remove “although for your own safety….to do
this.”
•
Under Confidentiality, last sentence: Delete
“[and DOB]” as this has not been identified
as an identifier in the application form.
Consent Form Review
Page 3:
Under Funding: Re-title this section as “What will this Study Cost Me?
Explain if the subject is required to present receipts for payment.
2nd paragraph: Delete this paragraph as the required information is
included in the new section “Who is Conducting the Study”.
Add the following standard wording regarding legal rights: You do not
waive any of your legal rights to compensation by signing this consent
form.
Under Further Information: “your physician Dr. Wendy Gordon” should be
a more defined role. Clarify her actual role in this study.
Please use consistent wording with respect to “study doctor”, “your
doctor”, “your physician”, “investigator (p. 4)”.
Clarify who is actually collecting the data – is it Dr. Wendy Gordon or the
subject’s actual physician at the clinic?
Also, please note that on page 4, Dr. Gordon is identified as a physician.
According to her C.V. she has a doctor of pharmacy degree. Please
delete “physician”.
Consent Form Review
Page 4:
Under #1: “research team members” should be defined.
Under # 6: Delete “independent ethics ….board” and use “the Fraser Health Research Ethics
Board”.
A word is missing in “other than that information protected by law.”
Clarify if “medical records” means the research-related records, as the review of medical records
has not been mentioned previously in the consent form.
Please clarify if this is part of the data collection and if so, specify review of the subject’s
medical records for collection of data in the section on “What Will Happen in the Study? “or
foreign regulatory authorities” should be removed.
Under #7: 1st sentence: Delete “and for treatment in this study” as there is no study
treatment taking place.
3rd sentence: Delete complete sentence, again as there is no treatment for research occurring
in this study.
Add the following items to the list on page 5:
I understand that all of the information collected will be kept confidential and that the result will
only be used for scientific objectives.
I understand that I am not waiving any of my legal rights as a result of signing this consent
form.
Add a line for the signature and printed name of a witness. The witness signature is an
attestation that the subject actually signed the consent form.
Add a signature and printed name line for the principal investigator.
Consent Form Review
•
•
•
•
The FHREB mandated changes as outlined above must be completed within six months;
otherwise a complete resubmission will be required. The form for reply to this request is
attached. Revisions of the consent should be clearly marked by using highlighted text.
Please email the response directly to Rosa Haywood at [email protected]
Ensure that the response to this letter and all subsequent documentation clearly utilizes the
FHREB identification number [e.g. 2007-010] and is signed by the researcher.
Recruitment of research subjects MUST not commence until the response has been
reviewed and approved by the co-Chair under the Expedited Review process, and the
certificate issued.
•
•
•
•
•
•
The FH REB Board membership consists of: Dr. A. Belzberg Co-Chair (Physician, Nuclear
Medicine), Dr. M.R. Foulkes Co-Chair (Physician, Anesthesia), Dr. Bob Gillies (Doctor of
Pharmacy), Dr. Arthur Friesen (Cardiologist), Prof. Lindsay Meredith (Ethicist), Ms. N.
Magnee (Lay Member), Dr. M. Vince (Biochemist, Clinical Laboratory Scientist), M. Wasdell
(Statistician), and alternating Ms. C. Ciarniello and Ms. M. Strickland (Lawyers with
Expertise in Health Care).
Dr. Marc Foulkes, Co-Chair
Fraser Health Research Ethics Board
MF/rh
While every effort has been taken to ensure the accuracy of this document, the signee has
not reviewed this copy and an electronic signature has been used; if you note any errors
please contact the Research Office as soon as possible.
FH RESEARCH REVIEW PROCESS
PI/designate submits
Appl’n to FH Research
for Expedited Review
Email
Application completed & submitted
to admin. supervisor for signature
Mail
Appl’n screened for completeness
No
No
1 business day
PI/designate submits
Appl’n to FH Research
for Full Board Review
Appl’n & consent form pre-reviewed
Yes
5 business days
10 business days
FHREB co-Chair conducts review
Yes
Study approved?
FHREB ‘approves’ Expedited
Review
5 business
days
Has all of the required
documentation been submitted?
No
5 business days
Request for
Deferral Notice sent
Modifications sent to PI
to PI
PI responds within 6
months
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate of Ethical Approval to PI
Full Board Review
Yes
Study Approved?
5 business days
If applicable, PI submits to FH Research:
•Signed DAR Form
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Contract for clinical trial research
•Health Canada No Objection Letter
EXPEDITED REVIEW PROCESS
Minimal Risk Applications, Amendments, & Renewals*
*U.S. regs apply to clinical trials
PI/designate submits appl’n to
FH Research for Expedited
Review
Email
Application completed & submitted
to admin. supervisor for signature
Expedited Renewal Applications:
Appl’n screened for completeness
No
1 business day
Yes
- Notice of Renewal sent to PI 4 weeks prior to due date
- PI to send Renewal Appl’n 2 weeks prior to due date
**NO NEW SUBJECTS CAN BE ENROLLED UNTIL
RENEWAL CERTIFICATE IS ISSUED**
5 business days
FHREB co-Chair conducts review
Yes
Application approved?
No
5 business days
FHREB ‘approves’ Expedited
Review
Request for
Modifications sent to PI
5 business
days
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate Approval to PI
Yes
Application Approved?
5 business days
For New Applications ONLY:
Has all of the required
documentation been submitted?
If applicable, PI submits to FH Research:
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Signed DAR Form
Last But Not Least
The Letter of Authorization to Conduct Research:
• FHREB initial approval
- consent
•
•
•
•
•
Health Canada Letter of No Objection
Clinical Trial Agreement
Department Agreement for Providing Researchrelated Services
Clinical Trial Registration #
Grant Agreement start date
Last but not least
HAVE FUN!
THANK YOU !!!
Susan Chunick
604-587-4681
Rosa Haywood
604-587-4436